MDR – MDCG update
The European commission has published two additional MDCG Guidance documents last week. MDCG 2020-9 Regulatory Requirements for Ventilators and Related Accessories.
MDCG 2019-3 Interpretation of Article 54(2) b rev.1 (Exempt devices from the premarket clinical evaluation consultation procedure).
FDA – GUDID Update
The FDA has updated their Data Elements Reference Table and the corresponding HL7 implementation file, which might require adaption of your GUDID upload procedure.
- GUDID Data Elements Reference Table April 27, 2020 –
Please see the ‘ChangeLog’ sheet for details on the updates. - GUDID HL7 SPL Implementation Files April 27, 2020 –
Please see the ‘ChangeLog’ sheet in the ‘ReadMeFirst.xls’ document for details on the updates.
COVID-19
APAC Region EUA Information
Several Countries in the APAC Region are still working on an Emergency Use Authorization (EUA) for Products during the COVID-19 pandemic.
India
Handling of Notarization and apostille could be difficult during the COVID-19 situation. The applicant may submit application for import license with such document which is self-attested and will be submitted notarized or apostilled later.
Saudi Arabia
The SFDA has updated and published some guidance documents:
- MDS-G47 Guidance on Requirements for Ventilators, Ventilator Tubing Connectors, and Ventilator Accessories – Recognized Standards
PDF download - Guidance on General Requirements for Medical Devices Manufacturing
PDF download - MDS – G46 Guidance on Requirements for Medical Masks - Recognized Standards
PDF download
Japan
PMDA implemented an organizational restructuring of Office of International Programs on April 1, 2020.
Taiwan
The Taiwan FDA published a set of pdf files for the draft of "Setting Standards for Medical Device Manufacturers" in May 2020.
- Announcement of Medical Equipment Manufacturers Setting Draft Standards PDF download
- General Explanation of Draft Standards Set by Medical Device Manufacturers PDF download
- The medical equipment manufacturers set the draft standards one by one
PDF download
Malaysia
The Ministry of Health Malaysia has published DRAFT MEDICAL DEVICE GUIDANCE DOCUMENT “MEDICAL GAS SYSTEM – REQUIREMENTS FOR REGISTRATION” for public comment.
All updates compiled in one PDF file:
You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.
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